It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and its extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions.

We provide Technical Support in the below mentioned Areas:

• Preparation of Drug Substance and Drug product registration dossier
• Dossier Preparation & Submissions Support in CTD
• Escort of registration procedures (MRP, DCP)
• Preparation of DMF  / CEP
• Independent GMP audit reports
• Regulatory strategy development and implementation
• Regulatory submission oversight, management, preparation, maintenance, and quality assurance
• Regulatory authority interactions, including serving as US Agent
• Regulatory compliance gap analysis and issue resolution
• Scientific, regulatory, and due diligence reviews of regulatory documents and submissions
• Regulatory and scientific document development, preparation, and quality assurance
• Drug Firm Establishment Registration with US-FDA
• Drug Listing in SPL [Structured Product labelling] format, Bulk Drug Listing
• NDC [National Drug Code] and Electronic submission